Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product

FDA Comment Number :

EC733

Submitter :

Mrs. Nicole Peck

Date & Time:

10/13/2005 08:10:28

Organization :

Mrs. Nicole Peck

Category :

Individual Consumer

Issue Areas/Comments

1

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?

I do not support simultaneously marketing a prescription drug and OTC drug.

1.

A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?

Again, I do not support this process.

GENERAL

GENERAL

The bottom line is that my family does not support marketing any kind of emergency contraception to anyone without a prescription! We must protect our children and they must obtain their parent's approval and physician prescription.